The Effects of Positive Airway Pressure on the Mucolytic Effects of NAC (TEAM)
NCT ID: NCT06152653
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
40 participants
INTERVENTIONAL
2024-04-09
2027-04-30
Brief Summary
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The main questions it aims to answer are:
* Does delivery of aerosolized NAC with positive inspiratory pressure have a greater effect on mucus plug burden in the lungs than delivery of NAC without positive pressure.
* Does delivery of aerosolized NAC with positive inspiratory pressure have a greater effect on lung function than delivery of NAC without positive pressure.
Participants will be assigned (in a single blind design) to the NAC via jet nebulizer group or the NAC via AeroEclipse-VersaPAP nebulizer group. Participants will each complete 5 treatment visits over the course of 30 days. Each treatment visit will consist of two treatments of a 10% NAC (3 mL) and 2.5 mg albuterol (0.5mL) inhalation solution separated by 4 hours, via the nebulization method specific to their group.
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Detailed Description
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Recent published work from the Fahy lab has revealed that airway mucus plugs can be identified on low dose CT scans of the lungs and quantified using a bronchopulmonary segment based system to generate a measure that quantifies the mucus plug burden in the lung. This CT based mucus plug scoring system provides a predictive and monitoring biomarker for mucus plug pathology in the lungs of patients with asthma and COPD.
This is a single-blind phase 4 clinical trial designed to help determine the optimal method of delivery of aerosolized NAC to patients with mucus-associated lung disease (asthma and COPD). Subjects will be screened for evidence of mucus in their lungs as determined by CT imaging. Eligible participants will then be assigned to the NAC via jet nebulizer group or the NAC via AeroEclipse-VersaPAP nebulizer group and complete 5 treatment visits over the course of 30 days. Each treatment visit will consist of two treatments of a 10% NAC (3 mL) and 2.5 mg albuterol (0.5mL) inhalation solution separated by 4 hours, via the nebulization method specific to their group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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NAC via jet nebulizer
NAC (trade name: Mucomyst) is manufactured by American Regent. The active drug studied here is 10% NAC coadministered with albuterol and delivered via standard jet nebulizer. Participants will each complete 5 treatment visits over the course of 30 days. Each treatment visit will consist of two treatments separated by 4 hours.
n-acetylcystine (NAC)+ albuterol
NAC is a mucolytic drug and Albuterol is a bronchodilator.
NAC via AeroEclipse-VersaPAP
NAC (trade name: Mucomyst) is manufactured by American Regent. The active drug studied here is 10% NAC coadministered with albuterol and delivered via the AeroEclipse-VersaPAP system. Participants will each complete 5 treatment visits over the course of 30 days. Each treatment visit will consist of two treatments separated by 4 hours.
n-acetylcystine (NAC)+ albuterol
NAC is a mucolytic drug and Albuterol is a bronchodilator.
AeroEclipse-VersaPAP System
The AeroEclipse-VersaPAP System combine continuous positive inspiratory pressure and nebulizer in one system.
Interventions
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n-acetylcystine (NAC)+ albuterol
NAC is a mucolytic drug and Albuterol is a bronchodilator.
AeroEclipse-VersaPAP System
The AeroEclipse-VersaPAP System combine continuous positive inspiratory pressure and nebulizer in one system.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Male or female between the ages of 18 to 85 at Visit 1
2. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
3. Able to perform reproducible spirometry according to American Thoracic Society (ATS) criteria
4. Clinical history of asthma per patient report or medical record
5. Asthma requiring treatment with inhaled corticosteroids (ICS) or biologic therapy for 3 months or greater
6. Computed Tomography (CT) mucus score ≥ 3 (done as part of screening)
7. There is no lower threshold on Forced Expiratory Volume in the first second (FEV1), which means the study will attempt to enroll all patients regardless of asthma severity. However, eligible participants will need to demonstrate ability to tolerate study treatment reflected by a post-treatment FEV1 ≥ 80% of pre- treatment, pre-bronchodilator FEV1. Participants who have a \>20% drop in FEV1 after receiving any study treatment will be excluded from the study.
8. For participants with known mucus plugging on CT: no limit on FEV1;
For participants with unknown mucus plugging: FEV1\<70% predicted
COPD Group:
1. Males or females between the ages 18 to 85 at the time of visit 1.
2. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
3. History of COPD per patient report or medical record and confirmed by an FEV1/FVC ratio of under 70%.
4. Current or former smoker with a history of at least 10 pack-years of smoking.
5. CT mucus score ≥ 3
6. There is no lower threshold on FEV1, which means the study will attempt to enroll all patients regardless of COPD severity. However, eligible participants will need to demonstrate ability to tolerate study treatment reflected by a post-treatment FEV1 ≥ 80% of pre- treatment, pre-bronchodilator FEV1. Participants who have a \>20% drop in FEV1 after receiving any study treatment will be excluded from the study.
7. For participants with known mucus plugging on CT: no limit on FEV1; For participants with unknown mucus plugging: FEV1\<50% predicted
Exclusion Criteria
2. Currently pregnant
3. URI in past 10 days
18 Years
85 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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John Fahy, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Professor of Medicine
Locations
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UCSF Airway Clinical Research Center
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Hays SR, Fahy JV. The role of mucus in fatal asthma. Am J Med. 2003 Jul;115(1):68-9. doi: 10.1016/s0002-9343(03)00260-2. No abstract available.
DUNNILL MS. The pathology of asthma, with special reference to changes in the bronchial mucosa. J Clin Pathol. 1960 Jan;13(1):27-33. doi: 10.1136/jcp.13.1.27.
Chui JY, de Anna P, Juanes R. Interface evolution during radial miscible viscous fingering. Phys Rev E Stat Nonlin Soft Matter Phys. 2015 Oct;92(4):041003. doi: 10.1103/PhysRevE.92.041003. Epub 2015 Oct 28.
Tang M, Elicker BM, Henry T, Gierada DS, Schiebler ML, Huang BK, Peters MC, Castro M, Hoffman EA, Fain SB, Ash SY, Choi J, Hall C, Phillips BR, Mauger DT, Denlinger LC, Jarjour NN, Israel E, Phipatanakul W, Levy BD, Wenzel SE, Bleecker ER, Woodruff PG, Fahy JV, Dunican EM. Mucus Plugs Persist in Asthma, and Changes in Mucus Plugs Associate with Changes in Airflow over Time. Am J Respir Crit Care Med. 2022 May 1;205(9):1036-1045. doi: 10.1164/rccm.202110-2265OC.
Other Identifiers
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23-39679
Identifier Type: -
Identifier Source: org_study_id
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